

Compass is a pre-configured, out-of-the-box, SaaS solution purpose-built to connect data across all functional areas of medical device product development, leveraging regulations such as 21 CFR 820.30 as well as standards ISO 13485, IEC 62366, and ISO 14971 as the foundation of the software design. It enables compliant product development by ensuring the process of authoring, reviewing, and releasing is enforced via workflows and built-in document templates, and automates a complex workflow between those interconnections to ensure compliant development. It provides an adaptable set of document templates for the entire product design control process from user needs to validation, with a focus on risk, requirement, and test management. Saving time and resources, it maintains documentation and supports submissions as well as provides automatic generation of the master trace matrices and documents for the Design History File (DHF), Technical Documentation Records, or audit support. Compass is best suited for small- to medium-sized medical device companies looking for guidance on how to bring their products to market with less risk. Compass offers guided compliance that is fully functional out of the box.

The Cockpit Platform is a validatable environment for product development. Cognition offers the Cognition Validation Kit, which enables companies to confirm the validation of the Cockpit Platform against GAMP 5 and AAMI TIR36-2007. You can either validate on your own or use Cognition's Validation Services to ease the burden

Cognition is an applied AI lab dedicated to advancing software engineering through artificial intelligence. Their flagship product, Devin, is the world's first AI software engineer, designed to collaborate with engineering teams to enhance productivity and innovation.
Cognition Corporation, headquartered in Lexington, Massachusetts, specializes in product development and compliance solutions for the life sciences industries. Our solutions focus on enhancing efficiency, quality, and compliance throughout the development process. For medical device companies, Cognition offers a design controls software platform, Compass MED, that helps meet regulations faster with real-time traceability, guided design controls, and change once, update everywhere functionality – turning manual and disconnected data into structured submissions that enable them to get to market faster. For pharmaceutical companies, Cognition’s Compass BIO software suite of applications for CMC module 3 reports —specifically created for pharma, biotech, and CDMO companies—is an innovative, technically driven digital CMC software solution to help biopharmaceutical companies navigate, organize, and generate the complex data tables and reports required for data management of projects and regulatory submissions without requiring manual data transcription and extensive data integrity checking. Compass BIO supports both large molecule (biologics) and traditional small molecule products. Unlike other solutions that simply replicate traditional documents and spreadsheets, Cognition takes a structured data approach so you can easily build relevant connections between data items, automatically create complex trace matrices and data tables, and export formatted documents instantly – offering a more efficient and integrated solution. We are shifting the data management landscape for life sciences product development from a static, document-based approach to a dynamic, information-driven approach helping to streamline and alleviate the administrative burden of product development documentation. Further information about Cognition Corporation can be found at www.cognition.us.